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NCT03263442 · ClinicalTrials.gov registry record · Phase 2
High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study of Delirium and Hematopoietic Stem Cell Transplantation, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03263442: Completed Phase 2 study of Delirium and Hematopoietic Stem Cell Transplantation, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03263442 is a Phase 2 study of Delirium and Hematopoietic Stem Cell Transplantation that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 66 participants, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263442, a Phase 2 study of Delirium and Hematopoietic Stem Cell Transplantation, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: To conduct a randomized controlled pilot study investigating the use of high dose intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium, including health-related quality of life (HRQOL), functional status, and neuropsychiatric outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic hematopoietic stem cell transplant (HSCT). Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for allogeneic stem cell transplant. Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will be measured weekly and participants will be assessed for evidence of delirium using validated measures. Validated measures will also be used to assess cognitive function, depression, post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at one, three, and six months after transplant.
Primary Outcome
Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of \> 12 has been suggested to distinguish patients with de
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Thiamine
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2020-08-10 |
| Phase | Phase 2 |
What the finished NCT03263442 record still lists
NCT03263442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Delirium appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT03263442 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03263442 about?
NCT03263442 is a clinical study titled "High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation". Purpose: To conduct a randomized controlled pilot study investigating the use of high dose intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium, including health-related quality of life (HRQOL), functional status, and neuropsychiatric outcomes, in patients adm...
What is the current status of trial NCT03263442?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2017-10-16. Estimated completion is 2020-08-10.
What conditions does trial NCT03263442 study?
This clinical trial studies the following conditions: Delirium, Hematopoietic Stem Cell Transplantation, Thiamine Deficiency.
What interventions are being tested in trial NCT03263442?
The interventions under investigation include: Normal saline (DRUG), Thiamine (DRUG).
Who is sponsoring clinical trial NCT03263442?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03263442 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03263442's enrollment target sits among peer trials
66 45th of 62 higher than 18 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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